Protocol Title: A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method for the Prevention of HIV Infection in Women
IPM 011 is an open-label crossover study designed to assess the safety and acceptability of a placebo vaginal ring (containing no drug) when inserted for a 12-week period in healthy sexually active women. The trial took place at multiple sites in Tanzania and South Africa, with participants being enrolled over a period of 24-26 weeks.
Data from IPM 011 indicated that use of a silicone vaginal ring for three months was safe and acceptable to African women.
- ClinicalTrials ID: NCT00469170
Participating Research Centers
- Reproductive Health and HIV Research Unit (RHRU) — Johannesburg, South Africa
- South Africa Medical Research Council (MCR) — Durban, South Africa
- Desmond Tutu HIV Foundation (DTHF) — Nyanga, South Africa
- Kilimanjaro Chrisitan Medical Centre (KCMC) — Moshi, Tanzania
Publications, presentations or other scientific data
- Poster- CROI 2011
- van der Straten et al. High acceptability of a vaginal ring intended as a microbicide delivery method for HIV prevention in African women. AIDS and Behavior 2012. See abstract.
- Montgomery et al. Vaginal ring adherence in sub-Saharan Africa: expulsion, removal, and perfect use. AIDS and Behavior 2012. See abstract.
- Nel et al. Safety of a silicone elastomer vaginal ring as potential microbicide delivery method in African women: A Phase 1 randomized trial. PLOS ONE 2018. See abstract.